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510(k) K192939

Volumetric Specimen Imager by Clarix Imaging — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2019
Date Received
October 18, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cabinet, X-Ray System
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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